FilmArray® Test Kits

1 Streamlined System. Many BioThreat Targets.

The FilmArray reagents pouch contains all the required reagents for sample preparation, PCR and detection in a freeze-dried, room temperature stable format making it the ideal system for any mobile lab. Prior to a run, the operator injects hydration solution and the unknown sample into the pouch. The FilmArray instrument does the rest.

First, the FilmArray extracts and purifies all nucleic acids from the unknown sample.

Next, the FilmArray performs a nested multiplex PCR. During the first-stage PCR, the FilmArray performs a single, large volume, massively multiplexed reaction.

Last, individual single-plex second-stage PCR reactions detect the products from the first stage PCR. Using endpoint melting curve data, the FilmArray software automatically generates a result for each target.

1 Test. 16 BioThreat Pathogens/26 Targets. All in about an hour.

The FilmArray BioThreat Panel tests for a comprehensive list of 16 threat pathogens. With just one test you can identify pathogens in environmental samples in about an hour with only 2 minutes of hands-on time.

The anthrax attacks of 2001 and the uncovering of recent bioterror plots highlight the importance of biodetection systems that can rapidly and accurately identify a wide range of potential biothreats in environmental samples (Schmitt and Shanker 2011; Kman and Bachmann 2012). An ideal system consistently detects the target organism(s) of interest at low levels without significant false-positive or false-negative results, interrogates a single sample for multiple targets (e.g. multiplexed detection), requires limited training and is cost-effective. One of the promising approaches to meet these needs is a detection system that identifies genetic signatures of biothreat pathogens using polymerase chain reaction (PCR). In this study, we evaluated a PCR-based detection system for the analysis of Bacillus anthracis (Ba), Yersinia pestis (Yp) and Francisella tularensis (Ft).

FilmArray Global Fever Panel

1 Test. 19 Targets. All in about an hour.

The RUO FilmArray Global Fever Panel tests for a comprehensive list of 6 bacterial, 9 viral and 4 protozan targets directly from whole blood. With just one test you can identify these targets in about an hour with only 2 minutes of hands-on time.

1 Test for Ebola Zaire virus
(detected in the West Africa outbreak in 2014)

The FilmArray BioThreat-E test is for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) on the FilmArray Instrument using whole blood and urine specimens in individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors.

This test has not been FDA cleared or approved;

This test has been authorized by FDA under an Emergency Use Authorization for use by CLIA Moderate and High Complexity Laboratories;

This test has been authorized only for the detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) and not for any other viruses or pathogens; and

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola Zaire virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

The EUA for the FilmArray BioThreat-E test enables CLIA moderate and high complexity laboratories to conduct a PCR test for Ebola in-house, providing results in approximately one hour.

Rapid Ebola virus (EBOV) detection is crucial for appropriate patient management and care. The performance of the FilmArray BioThreat-E test (v2.5) using whole-blood samples was evaluated in Sierra Leone and the United Kingdom and was compared with results generated by a real-time Ebola Zaire PCR reference method. Samples were tested in diagnostic laboratories upon availability, included successive samples from individual patients, and were heat treated to facilitate EBOV inactivation prior to PCR. The BioThreat-E test had a sensitivity of 84% (confidence interval [CI], 64% to 95%) and a specificity of 89% (CI, 73% to 97%) in Sierra Leone (n = 60; 44 patients) and a sensitivity of 75% (CI, 19% to 99%) and a specificity of 100% (CI, 97% to 100%) in the United Kingdom (n = 108; 70 patients) compared to the reference real-time PCR. Statistical analysis (Fisher’s exact test) indicated there was no significant difference between the methods at the 99% confidence level in either country. In 9 discrepant results (5 real-time PCR positives and BioThreat-E test negatives and 4 real-time PCR negatives and BioThreat-E test positives), the majority (n = 8) were obtained from samples with an observed or probable low viral load. The FilmArray BioThreat-E test (v2.5) therefore provides an attractive option for laboratories (either in austere field settings or in countries with an advanced technological infrastructure) which do not routinely offer an EBOV diagnostic capability.